Propofol Effects on Mitral Valve Annular Velocity

The Effect of Propofol on Tissue Doppler Imaging of Mitral Valve Annular Velocity During Remifentanil-based Cardiac Anesthesia

The purpose of this study is primarily to determine the effects of propofol at different concentration on the mitral valve annulus by using Tissue Doppler Imaging

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Valvular Heart Disease
• Intervention / Treatment: Drug: Propofol 1.0mcg; Drug: Propofol 2.0mcg; Drug: Propofol 3.0mcg

Detailed Description

The purpose of this study is to evaluate the effects of different concentration of propofol on patients who are undergoing cardiac surgery. The patients will receive infusion remifentanil 0.5mcg/kg/min with different target-site propofol concentration namely 1.0ng/ml, 2.0ng/ml and 3.0ng/ml. Tissue Doppler Imaging by transesophageal echocardiography will be done to assess the changes in cardiac function.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

patients undergoing cardiac surgery

Exclusion Criteria:

low ejection fraction < 50% on transthoracic echocardiography atrial fibrillation pacemaker pericardial and infiltrative myocardial disease mitral annular calcification, surgical rings, prosthetic mitral valve lateral left ventricular wall motion abnormality oesophageal abnormality history of extensive radiation to the mediastinum upper gastrointestinal bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol 1.0mcg; Propofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 1.0mcg/ml using target controlled infusion.	Drug: Propofol 1.0mcg; Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.; Other Names: Fresofol (2% propofol, Fresinius Kabi)
Experimental: Propofol 2.0mcg; Propofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 2.0mcg/ml using target controlled infusion.	Drug: Propofol 2.0mcg; Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.; Other Names: Fresofol (2% propofol, Fresinius Kabi)
Experimental: Propofol 3.0mcg; Propofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 3.0mcg/ml using target controlled infusion.	Drug: Propofol 3.0mcg; Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion; Other Names: Fresofol (2% propofol, Fresinius Kabi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of systolic mitral valve annular velocity (S')	To examine the effect of Propofol at different effect-site concentration ( 1.0 ng/ml, 2.0 ng/ml and 3.0 ng/ml) on S' (systolic mitral valve annular velocity) during remifentanil-based anesthesia.	10 min after achieving 3 different propofol concentrations

Secondary Outcome Measures

Outcome Measure	Time Frame
Early diastolic mitral valve annular velocity (e')	10 min after achieving 3 different propofol concentrations
late diastolic (atrial contractile) mitral valve annular velocity (a')	10 min after achieving 3 different propofol concentrations
ejection fraction	10 min after achieving 3 different propofol concentrations
phenylephrine infusion rate	10 min after achieving 3 different propofol concentrations

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Tae-yop Kim, MD, PhD, Konkuk University Medical Center, Seoul, Korea, Republic of

Publications and helpful links

General Publications

• Bang JY, Kim S, Choi BM, Kim TY. Pharmacodynamic Analysis of the Influence of Propofol on Left Ventricular Long-Axis Systolic Performance in Cardiac Surgical Patients. J Korean Med Sci. 2019 Apr 29;34(16):e132. doi: 10.3346/jkms.2019.34.e132.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Heart Valve Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: KUH1160053